FDA 510(k) clearances — page 615
clearances on record, most recent first.
Clearances — page 615
61,401–61,500 of 176,637- K063557 — PEAK BOND, MODEL 5133
- K063657 — VASCUTRAK PTA DILATION CATHETER
- K052509 — M-BOLUS EMBOLIC MICROSPHERES
- K060694 — MODULAR HYBRID GLENOID
- K061533 — PROCEED VENTRAL PATCH
- K061875 — MINISPIR; SPIROLAB III
- K062280 — OSTENE, AOC, OSTEOTENE, CERETENE, CEREPOR, APTENE, APATENE AND ACTIPASTE
- K062602 — BAND-AID(R) BRAND LIQUID BANDAGE
- K062760 — ORI F6T DRY ECG MONITORING ELECTRODE
- K062791 — USI DENTAL SCALER, 25XXX SERIES
- K062795 — MUGARD MUCOADHESIVE ORAL WOUND RINSE
- K063087 — MODIFICATION TO MODEL 750 SERIES MONITOR
- K063180 — ISECURE SYRINGE CARTRIDGE HOLDER
- K063239 — LIFESHIELD LATEX-FREE GRAVITECH FLOW CONTROLLER I.V. SETS, MODELS 17528, 17527, 17525 & 17526
- K063379 — AMEDICA DRUG SCREEN THC, COC, OPI, AMP, MET, PCP, MDMA, BAR, BZO, M, MODELS C1210, C1220
- K063402 — WICK ELECTRODE, MODEL M019260
- K063428 — XIA STAINLESS STEEL SPINAL SYSTEM
- K061902 — COSYTHERM, MODELS NCM1, NCM2, NCB1, CCU1, CRU1
- K062211 — BIOPLEX 2200 EBV IGG PANEL FOR BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM
- K062213 — BIOPLEX 2200 EBV IGM PANEL ON BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM
- K062367 — MINISCREWS ANCHORING SYSTEM, M.A.S.
- K062707 — RUDOLF INNOVIEW AUTOCLAVABLE SEMI-RIGID URETERO-RENOSCOPE
- K062710 — GE DATEX-OHMEDA ENGSTROM CARESTATION
- K062796 — K-Y BRAND INTRIGUE
- K062948 — SMART GBS AND SMARTCYCLE DX SYSTEM AND SOFTWARE, VERSION 1.7B
- K062986 — MEDTRONIC GRAFT DELIVERY SYRINGE
- K062997 — ARCOMXL POLYETHYLENE LINERS AND 38/40MM FEMORAL HEADS
- K063142 — MANUAL PD-IO; POWERED PD-IO
- K063214 — EVER LIGHT PLASTIC PRODUCTS CO., LTD. POWDERED (WHITE) VINYL PATIENT EXAMINATION GLOVES
- K063215 — EVER LIGHT PLASTIC PRODUCTS CO., LTD. POWDERED (YELLOW) VINYL PATIENT EXAMINATION GLOVES
- K063228 — SURFACE COAT
- K063237 — THERACAL LC
- K063301 — BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFEPIME (GN) 0.5-64UG/ML
- K063334 — SHANGHAI GANGHAI MODEL GIKO 1400
- K063365 — SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH GENTAMICIN (0.06-32MG/ML LONG DILUTION SEQUENCE
- K063366 — MICROSCAN SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANEL WITH SYNERCID (0.12-2UG/ML 5DILUTION BREAKPOINT SEQUENCE
- K060839 — ABC HAIR REMOVAL SYSTEM
- K061484 — MODIFICATION TO: SMITHWICK CAROTID SHUNT
- K062001 — ROSTAM SCENTED AND UNSCENTED PLASTIC APPLICATOR TAMPONS
- K062752 — MERCATOR MICROSYRINGE II INFUSION CATHETER
- K062794 — PRN THERMALCARE, MODEL 3000
- K063153 — NOVAPACS
- K063200 — 20.1-INCH (51CM) COLOR LCD MONITOR CDL2010A (CCL204)
- K063254 — THE TRUFILL DCS DETACHABLE COIL SYSTEM; THE TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM
- K063416 — LUXVISION SLIT LAMP
- K063460 — ACUMED CONGRUENT BONE PLATE SYSTEM
- K051817 — BOOMERANG CLOSUREWIRE VASCULAR CLOSURE SYSTEM
- K060988 — TOTAL AND HEMI SHOULDER SYSTEM
- K061276 — G-PROX ENDOSCOPIC GRASPER
- K061436 — PALOMAR Q-YAG 5 ND:YAG LASER SYSTEM
- K061805 — STA - STACLOT DRVV SCREEN; STA - STACLOT DRVV CONFIRM
- K061844 — DYNASTY ACETABULAR SHELL AND COCR ACETABULAR LINER
- K062324 — MRI MONITOR WITH L-CANE05 AND L-CANE05A SOFTWARE AND MODULE OPTIONS N-PSNGV, N-PSNG, N-SNGV, N-SNG, N-PSN, N-SN
- K062364 — I-SCOPE 200
- K062566 — NOBELREPLACE TAPERED CONICAL CONNECTION
- K062664 — HUMIDCARE HEATED HUMIDIFIER, MODEL 9S-004
- K062709 — POWDER FREE LATEX EXAMINATION GLOVES, BLACK
- K062867 — MICROLIFE INSTANT DIGITAL ELECTRONIC THERMOMETER, MODEL QT1JC1
- K062915 — VERITAS COLLAGEN MATRIX
- K063374 — NITINOL LOCKING INCUDO-STAPEDIAL JOINT, ANGULAR PISTON, PISTON, MALLEUS PISTON, PORP AND FOOTPLATE SHOE
- K063500 — DC-6 DIAGNOSTIC ULTRASOUND SYSTEM
- K052719 — URITEST 10 URINALYSIS REAGENT STRIPS
- K062100 — ARJOWRAP 47/100 AND 47/88
- K062435 — REPAIR KIT FOR XPRESSO, DECATHLON, AND ALTA LR CATHETERS
- K062508 — NEUROWAVE MICRO-INFUSION SYSTEM
- K062956 — EZ-MIO, EZ-IO DISTAL TIBIA
- K063045 — IMMULITE 2000, IMMULITE 2500 VANCOMYCIN
- K063116 — DEMETRON A.2
- K063213 — EVER LIGHT PLASTIC PRODUCTS CO., LTD. POWDER FREE (WHITE) VINYL PATIENT EXAMINATION GLOVES
- K063313 — FILTERWIRE EZ EMBOLIC PROTECTION SYSTEM (3.5 MM TO 5.5 MM)
- K063398 — ESA LEADCARE II LEAD CONTROL
- K063457 — TRUEHD (1080P) DIGITAL CAMERA SYSTEM
- K061466 — INTIMOL
- K061726 — LSC, MODEL 3
- K062045 — EDIA ANTI-CCP
- K062371 — PREVIEW ANTERIOR CERVICAL PLATE SYSTEM
- K062518 — CELERITY
- K062750 — WALLFLEX ENTERAL DUODENAL STENT WITH ANCHOR LOCK DELIVERY SYSTEM, MODELS M00565010, M00565020, M00565030
- K062769 — PRESSUREWIRE CERTUS, MODELS 12006 AND 12306
- K062819 — BIOPLATE RIGID BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY
- K062842 — TWIST DRILL
- K063030 — COMFORT SCOOTER MODEL LY-EW406
- K063194 — TUFFLEX POLYESTER SUTURE
- K063199 — 21.3-INCH (54CM) COLOR LCD MONITOR CDL2120A (CCL252I2)
- K063308 — ADVACOAT SINUS GEL, MODEL 9100, ADVA SINUS STENT, MODEL 9200
- K063419 — MODIFICATION TO VSM- VITAL SIGNS MONITOR, (VSM 300 )
- K060792 — ILLUMIMED
- K061712 — SPIROBANK II
- K061937 — COOK ENDOSCOPY ESOPHAGEAL DILATION BALLOON
- K062539 — NCONTACT COAGULATION SYSTEM KIT
- K062674 — MISSION TRINITY B
- K062719 — GREENLIGHT HPS SERIES SURGICAL LASER SYSTEM & ACCESSORIES
- K062960 — CONSERVE FEMORAL RESURFACING COMPONENT
- K063012 — NCONTACT COAGULATION SYSTEM KIT, MODEL CSK
- K063013 — PLEATS PLUS N95 RESPIRATOR, MODELS 1054 AND 1054S
- K063025 — LINA POWERBLADE, MODEL 5005,5005-E,5005-C,5005-150,5000-C-150,5005-E-C-150,5005-420,5005-C-420,5005-E-420,5005-E-C-420,
- K063062 — HKBOND 2006
- K063112 — REVLITE Q-SWITCHED ND:YAG LASER
- K063220 — DA VINCI S SURGICAL SYSTEM-V1.1, MODEL IS2000
- K063400 — VARIANT II TURBO HEMOGLOBIN A1C PROGRAM, HEMOGLOBIN TESTING SYSTEM WITH CDM 4.0
Data sourced from openFDA. This site is unofficial and independent of the FDA.